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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameXPS WITH STEEN SOLUTION PERFUSATE
Classification Namenormothermic preservation system for transplantation of initially unacceptable donor lungs
Generic Namenormothermic preservation system for transplantation of initially unacceptable donor lungs
Applicant
Xvivo Perfusion
3666 s inca st.
englewood, CO 80110
HDE NumberH120003
Supplement NumberS004
Date Received10/23/2014
Decision Date04/10/2015
Product Code
PHO[ Registered Establishments with PHO ]
Advisory Committee Gastroenterology
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval of the post-approval study protocol.
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